ANSM Safety Alert: Eonis SCID-SMA Kit for Genetic Testing

Detected March 20th, 2026

Summary

The French ANSM has issued a safety alert regarding the Eonis SCID-SMA kit for genetic testing, manufactured by Wallac/Revvity. Affected users have been notified directly by the company, and the alert is registered under ANSM reference R2607970.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert concerning the Eonis SCID-SMA kit used for genetic testing. This alert, registered under reference R2607970, follows a security action initiated by the manufacturer, Wallac/Revvity. The notice indicates that affected users have already received direct communication from the company regarding this action.

Laboratories of medical biology that use this kit should be aware of this safety action. While the ANSM is registering the alert, direct inquiries and actions should be addressed to Wallac/Revvity. The document provides a link to the company's letter, dated March 20, 2026, which contains the specific details of the security action and any required steps for users.

What to do next

Review communication from Wallac/Revvity regarding the Eonis SCID-SMA kit
Direct any questions regarding the security action to Wallac/Revvity

Source document (simplified)

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Information n° R2607970 destinée aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Wallac / Revvity.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607970. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Wallac / Revvity (20/03/2026)